For Patients

Mirapex (pramipexole) is a dopamine agonist medication used to treat symptoms of Parkinson's disease, and restless legs syndrome. The most common side effects of Mirapex are dizziness when standing (postural hypotension), nausea, dry mouth, stomach pain, vomiting, constipation, headache, dizziness, spinning sensation, drowsiness, swelling in your hands and feet, appetite or weight changes, blurred vision, sleep problems (insomnia or unusual dreams), memory problems (amnesia), forgetfulness, confusion or thinking problems, impotence, loss of interest in sex, or trouble having an orgasm. It may take a few weeks for full effects of this medication to be noticed.

Mirapex is taken in tablet form three times per day. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can worsen the sleepiness caused by pramipexole. This list is not complete and there may be other drugs that can interact with pramipexole. Alcohol can also increase the side effects. During pregnancy, this medication should be used only when clearly needed. Although very unlikely, if you suddenly stop taking this drug, withdrawal reactions may occur, including fever and confusion.

Our Mirapex Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people taking pramipexole have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with pramipexole, including up to 1 year after starting the medication. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.

You may also develop a sudden drop in blood pressure, which can cause dizziness, nausea, sweating, and fainting. This is more likely when you are first starting the medication, when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in clinical practice.

Parkinson's Disease

During the premarketing development of pramipexole,
patients with either early or advanced Parkinson's disease were enrolled in
clinical trials. Apart from the severity and duration of their disease, the two
populations differed in their use of concomitant levodopa therapy. Patients
with early disease did not receive concomitant levodopa therapy during
treatment with pramipexole; those with advanced Parkinson's disease all
received concomitant levodopa treatment. Because these two populations may have
differential risks for various adverse reactions, this section will, in
general, present adverse-reaction data for these two populations separately.

Because the controlled trials performed during
premarketing development all used a titration design, with a resultant
confounding of time and dose, it was impossible to adequately evaluate the
effects of dose on the incidence of adverse reactions.

Early Parkinson's Disease

In the three double-blind, placebo-controlled trials of
patients with early Parkinson's disease, the most common adverse reactions
( > 5%) that were numerically more frequent in the group treated with MIRAPEX
tablets were nausea, dizziness, somnolence, insomnia, constipation, asthenia,
and hallucinations.

Approximately 12% of 388 patients with early Parkinson's
disease and treated with MIRAPEX tablets who participated in the double-blind,
placebo-controlled trials discontinued treatment due to adverse reactions compared
with 11% of 235 patients who received placebo. The adverse reactions most commonly
causing discontinuation of treatment were related to the nervous system
(hallucinations [3.1% on MIRAPEX tablets vs 0.4% on placebo]; dizziness [2.1%
on MIRAPEX tablets vs 1% on placebo]; somnolence [1.6% on MIRAPEX tablets vs 0%
on placebo]; headache and confusion [1.3% and 1.0%, respectively, on MIRAPEX
tablets vs 0% on placebo]) and gastrointestinal system (nausea [2.1% on MIRAPEX
tablets vs 0.4% on placebo]).

Adverse-reaction Incidence in Controlled Clinical
Studies in Early Parkinson's Disease

Table 4 lists adverse reactions that occurred in the
double-blind, placebo-controlled studies in early Parkinson's disease that were
reported by ≥ 1% of patients treated with MIRAPEX tablets and were
numerically more frequent than in the placebo group. In these studies, patients
did not receive concomitant levodopa.

In a fixed-dose study in early
Parkinson's disease, occurrence of the following reactions increased in
frequency as the dose increased over the range from 1.5 mg/day to 6 mg/day:
postural hypotension, nausea, constipation, somnolence, and amnesia. The
frequency of these reactions was generally 2-fold greater than placebo for
pramipexole doses greater than 3 mg/day. The incidence of somnolence with
pramipexole at a dose of 1.5 mg/day was comparable to that reported for
placebo.

Approximately 12% of 260
patients with advanced Parkinson's disease who received MIRAPEX tablets and
concomitant levodopa in the double-blind, placebo-controlled trials
discontinued treatment due to adverse reactions compared with 16% of 264
patients who received placebo and concomitant levodopa. The reactions most
commonly causing discontinuation of treatment were related to the nervous
system (hallucinations [2.7% on MIRAPEX tablets vs 0.4% on placebo]; dyskinesia
[1.9% on MIRAPEX tablets vs 0.8% on placebo] and cardiovascular system
(postural [orthostatic] hypotension [2.3% on MIRAPEX tablets vs 1.1% on
placebo]).

Table 5 lists adverse reactions
that occurred in the double-blind, placebo-controlled studies in advanced
Parkinson's disease that were reported by ≥ 1%
of patients treated with MIRAPEX tablets and
were numerically more frequent than in the placebo group. In these studies,
MIRAPEX tablets or placebo was administered to patients who were also receiving
concomitant levodopa.

Restless Legs Syndrome

MIRAPEX tablets for treatment
of RLS have been evaluated for safety in 889 patients, including 427 treated
for over six months and 75 for over one year.

The overall safety assessment
focuses on the results of three double-blind, placebo-controlled trials, in
which 575 patients with RLS were treated with MIRAPEX tablets for up to 12
weeks. The most common adverse reactions with MIRAPEX tablets in the treatment
of RLS (observed in > 5% of pramipexole-treated patients and at a rate at
least twice that observed in placebo-treated patients) were nausea and
somnolence. Occurrences of nausea and somnolence in clinical trials were
generally mild and transient.

Approximately 7% of 575
patients treated with MIRAPEX tablets during the double-blind periods of three
placebo-controlled trials discontinued treatment due to adverse reactions
compared to 5% of 223 patients who received placebo. The adverse reaction most
commonly causing discontinuation of treatment was nausea (1%).

Table 6 lists reactions that
occurred in three double-blind, placebo-controlled studies in RLS patients that
were reported by ≥ 2% of patients treated with MIRAPEX tablets and were
numerically more frequent than in the placebo group.

Adverse Reactions: Relationship
to Age, Gender, and Race

Among the adverse reactions in
patients treated with MIRAPEX tablets, hallucination appeared to exhibit a
positive relationship to age in patients with Parkinson's disease. Although no
gender-related differences were observed in Parkinson's disease
patients, nausea and fatigue, both generally transient, were more frequently reported
by female than male RLS patients. Less than 4% of patients enrolled were
non-Caucasian: therefore, an evaluation of adverse reactions related to race is
not possible.

Laboratory Tests

During the development of MIRAPEX tablets, no systematic
abnormalities on routine laboratory testing were noted.

Post Marketing Experience

In addition to the adverse events reported during
clinical trials, the following adverse reactions have been identified during
post-approval use of MIRAPEX tablets, primarily in Parkinson's disease
patients. Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their frequency
or establish a causal relationship to drug exposure. Decisions to include these
events in labeling are typically based on one or more of the following factors:
(1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of
causal connection to pramipexole tablets. Similar types of reactions were
grouped into a smaller number of standardized categories using the MedDRA
terminology: cardiac failure, inappropriate antidiuretic hormone secretion
(SIADH), syncope, vomiting, and weight increase.